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Cerebral Autoregulation in Patients With Epilepsy

Cerebral Autoregulation in Patients With Epilepsy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02775682
Acronym
CAPE
Enrollment
200
Registered
2016-05-18
Start date
2016-04-30
Completion date
2017-05-31
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy, dynamic cerebral autoregulation

Brief summary

The purpose of this study is to determine whether patients with epilepsy exhibiting impaired dCA, which may contribute to subsequent stroke.

Detailed description

The relationship between epileptic seizures and cerebrovascular disease is complex, ranging from mechanisms to clinical manifestation. Stroke is one of the most common causes of epilepsy in adulthood. It was also reported that patients with epilepsy exhibited a higher risk of stroke. But its potential mechanism was never fully understood. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral bold flow, has been proved to be critical for the occurrence ,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that impaired dCA play a role in epilepsy and subsequent stroke.

Interventions

None listed

Sponsors

Yi Yang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* patients with epilepsy, as diagnosed by EEG

Exclusion criteria

* patients with status epilepticus * intracranial and/or extracranial major vascular stenosis/occlusion diagnosed by a transcranial Doppler (EMS-9PB, Delica, China) and carotid ultrasound (IU22, Phillips, Andover, MA) * a prior symptomatic cerebral vascular disease * a history of hypertension, cardiovascular disease, diabetes, hyperlipemia, current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability, or inability to cooperate sufficiently to complete the cerebral auto regulation examination * insufficient bilateral temporal bone windows for insonation of the middle cerebral artery * intolerance to cerebral autoregulation measurements

Design outcomes

Primary

MeasureTime frameDescription
phase difference(PD) in degree1 yearA dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.

Secondary

MeasureTime frameDescription
the rate of recovery of cerebral blood flow velocity1 yearA dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome
gain in cm/s/mmHg1 yearA dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome
the consequence of electroencephalograph(EEG)1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026